ESSENTIO™ MRI EL DR

GUDID 00802526559006

Pacemaker

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive
Primary Device ID00802526559006
NIH Device Record Key2c51ad95-107a-415c-bf1a-58b0b8003efb
Commercial Distribution StatusIn Commercial Distribution
Brand NameESSENTIO™ MRI EL DR
Version Model NumberL131
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526559006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWPImplantable pulse generator, pacemaker (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-04
Device Publish Date2016-05-10

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

00191506034429 - RHYTHMIA HDx™2024-03-11 Ablation Connection Box
00191506020408 - IntellaNav StablePoint™ Cable2024-03-08 Catheter Cable
08714729419396 - Percuflex™2024-03-08 Ureteral Stent
08714729992233 - INTELLANAV STABLEPOINT™2024-03-08 Ablation Catheter
08714729992240 - INTELLANAV STABLEPOINT™2024-03-08 Ablation Catheter
00191506019570 - Rubicon™ Control2024-02-26 Support Catheter
00191506019594 - Rubicon™ Control2024-02-26 Support Catheter
00191506019617 - Rubicon™ Control2024-02-26 Support Catheter

Trademark Results [ESSENTIO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESSENTIO
ESSENTIO
85873570 4813272 Live/Registered
Cardiac Pacemakers, Inc.
2013-03-12
ESSENTIO
ESSENTIO
79244262 not registered Live/Pending
FABER-CASTELL AKTIENGESELLSCHAFT
2018-09-07
ESSENTIO
ESSENTIO
77616866 3727384 Dead/Cancelled
ASUSTEK COMPUTER INCORPORATION
2008-11-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.